Creating Miracles in Life

Transcription

1 Creating Miracles in Life November 2017 China Biologic Products Holdings, Inc. (NASDAQ: CBPO)

2 Safe Harbor Statement 01 This presentation contains forward-looking statements, including statements about the business outlook, strategy and market opportunity of China Biologic Products Holdings, Inc. (the Company or we ), and statements that may suggest trends for its business. Such forward-looking statements can be identified by the use of forward-looking terminology such as anticipate, believe, could, estimate, expect, intend, may, plan, potential, should, will, would, and similar expressions, or the negatives thereof. These statements are individually and collectively forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of These forward-looking statements are made only as of the date of this presentation and are based on estimates and information available to the Company at the time of this presentation. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict and may be beyond the Company s control. Therefore, the Company cautions that actual results may differ materially from those set forth in any forward-looking statements herein, and are subject to numerous assumptions, risks, uncertainties and other factors, including those discussed under Risk Factors in the Company s annual report on Form 10-K filed with the SEC for the year ended December 31, In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Any forward-looking statements and projections made by others in this presentation are not adopted by the Company and the Company is not responsible for the forward-looking statements and projections of others. Except as otherwise required by applicable securities laws, the Company disclaims any intention or obligation to publicly update or revise forward-looking statements, whether as a result of new information, future events or otherwise. In evaluating our business, we use certain non-gaap measures as supplemental measures to review and assess our operating performance. These non-gaap financial measures have limitations as analytical tools and investors should not consider them in isolation, or as a substitute for net income attributable to Company or other consolidated statement of comprehensive income data prepared in accordance with U.S. GAAP.

3 CBPO: A Leading Plasma Company in China 02 Business Overview Market Position A fully integrated plasma-based biopharmaceutical company in China 8 categories of plasma-based products Headquartered in Beijing, with 3 production facilities (1 wholly owned (1), 1 majority owned and 1 minority owned) Founded in 2002 and listed on NASDAQ in 2009 (Ticker: CBPO) One of top three domestic suppliers in China for the two principal plasma products One of the first plasma companies in China to penetrate into end-user market, directly serving approximately 600 hospitals and clinics Capital Structure Price: $80.4 (10/27/2017) Market Capitalization: $2.2 billion 52-Week Range: $ $ Shares Outstanding: 27.6 mm Selected 3Q 17 Financials Revenue: $99.6 mm, up 15.1% in both RMB terms and USD terms y-o-y (2) Gross Profit: $67.1 mm, up 14.0% y-o-y; Gross Margin: 67.4% Operating Income: $38.0 mm, down 4.2% y-o-y; Operating Margin: 38.2% Net Income: $31.6 mm, up 11.2% y-o-y Non-GAAP Net Income (3) : $39.4 mm, up 14.8% in both RMB terms and USD terms y-o-y (2) Fully diluted EPS: $1.11; Non-GAAP EPS (3) : $ Weacquired the fully equity ownership in Guizhou Taibang through capital withdrawal by its former minority stockholders in November We believe providing local currency information on certain key items of our financial results enhances the understanding of our financial results and evaluation of performance in comparison to prior periods. We calculate changes in local currency percentages by comparing financial results denominated in RMB from period to period. 3. Refer to Appendix I for reconciliation of Non-GAAP net income attributable to equity holders

4 CBPO Plasma Product Overview 03 Blood IVIG 30.9% Other immunoglobulins 14.9% White cells CBPO Sales Breakdown by Product P. Polypeptide 15.1% Red cells Platelets ( Q3 17 Sales % ) Albumin 33.0% Others 6.2% Plasma CBPO is among top 3 domestic players in each of China albumin and IVIG market (1) Albumin Maintain osmotic pressure, etc. 90% Water 7% Proteins 3% Salt Fractionation Infections, immune deficiencies (IVIG) lmmunoglobulins Hyper- Immunoglobulins Hepatitis Rabies Tetanus etc. Clotting factors FVIII PCC Fibrinogen etc. Foreign Player E Foreign Player D Others Foreign Player C Foreign Player B CBPO 6.5% Albumin Domestic player 1 Domestic player 2 Foreign players Foreign Player A Others IVIG Domestic player 2 CBPO 14.9% Domestic player 1 Source: Company estimates on 2016 production volume based on the public release of government batch approval data. 1. Excludes sales attributable to Xi an Huitian, in which we hold a 35% non-controlling interest.

5 China Biologic Products, Inc. Industry Overview China Biologic Products Holdings, Inc.

6 China s Plasma Protein Market Early Stage of Growth, Low Penetration, Significant Potential 05 China Plasma Products (1) Market Size ($ Billion) China is the second largest plasma products market in the world Significant unmet clinical demand provides sustainable growth Growth potential driven by aging population and various diseases Seller s market with sustainable pricing 2015 Plasma Products Per Capita Usage 0.0 IVIG 27.2% Plasma Products (1) Structure Comparison Hyperimmune 6.5% ( By 2015 Product Sales ) FVIII 1.5% Others 1.0% FVIII 2.5% Alpha-1 Antitrypsin 8.1% C-1 Esterase Inhibitor 8.2% Per Capita Usage in US / Per Capita Usage in China (x) 2015 Market Size in China ($ MM) (2) 14.0x (2) (3) 7.7x 2.5x Albumin IVIG Factor VIII 1, China Albumin 63.8% IVIG&SCI G 57.2% U.S. In China, albumin is the largest product in plasma products market. In U.S., IVIG is the largest product, and various coagulation factor products are growing fast. Others 17.0% Albumin and plasma protein fraction 7.0% China s 2015 market size is $2.5 billion, but its per capita penetration is still a fraction of that of the U.S. Source: The Marketing Research Bureau, Inc. and Company estimates 1. Excluding recombinant products 2. Based on 2015 per capita usage (kilogram per MM inhabitant) in U.S. divided by 2015 per capita usage in China 3. Based on 2015 per capita usage (international units per capita) in U.S. divided by 2015 per capita usage in China, excluding recombinant products

7 High Barriers to Entry Benefit Established Players 06 China will continue to maintain stringent regulations for the plasma product industry as it is critical to China's public health security Regulatory framework in China has evolved into one of the most stringent globally due to crises of tainted plasma products over the past decade Fractionators permitted to process self-collected plasma only as required by law New plasma collection licenses are difficult to obtain New plasma fractionation licenses ceased to be granted since 2001; 28 licensed manufacturers of plasma products are currently in operation Since 1986, all imported blood products have been banned except for human albumin and recombinant factor VIII products In December 2016, a new guideline was released, which included granting more licenses for new plasma collection stations preferably to larger companies that can improve plasma quality and safety controls

8 Plasma Collection Regulation Environment U.S. vs. China 07 United States China Population (million) 319 1,363 Donation Frequency Collection Volume Twice per 7 days, not within 48 hours Volumes by weight 50-68kg / 69-79kg / >79kg, donate 690 / 825 / 880 ml Twice per month, not within 14 days 580 ml Plasma Collection Centers Approximately 601 Approximately 218 Preapproval Requirement No Yes Plasma Donation Compensation (for one time donation) $25-35 $42-50 Regulation Agencies Food and Drug Administration (FDA) and Plasma Protein Therapeutics Association (PPTA) County-, Municipal- and Provincial- Level Governments Plasma Collected in 2016 (million liters) Approximately 35.0 Approximately 7.2 Source: Broker Report, The Marketing Research Bureau, Inc., Plasma Protein Therapeutics Association (PPTA) and Company estimates

9 Plasma Is An Attractive Sector For Investment In China Pharmaceutical Industry 08 Plasma Companies Other Pharma Companies Commentary Regulatory Control Supply / Demand Historical Pricing Domestic Competition Foreign Competition Sales and Distribution Growth Visibility China s plasma-derived products market is highly regulated by the government Significant supply shortage favors leading plasma players Prices for most plasma products have remained steady whereas the average price of many pharma products has been in decline 28 active plasma product manufacturers in China vs. thousands of pharmaceutical companies Currently only albumin and recombinant factor VIII are open to imports Compared with pharmaceutical companies, the plasma industry in China is a seller s market Growth among plasma manufacturers is primarily driven by the supply/demand imbalance

10 Albumin: Largest Market with Growth Potential 09 China is the world s largest albumin market, but per capita usage is still lower than U.S. Consistent price increases since Price ceiling has been removed since June 1, 2015 Growth in disease prevalence and patient pool, such as hypoalbuminemia from liver cirrhosis and hepatitis B Plasma collection volume continues to grow Albumin Sales in China Albumin Per Capita Usage in 2015 ($ MM) 2,000 1,600 1,574 (Kg per MM Inhabitants) x , China United States Source: The Marketing Research Bureau, Inc. and Company estimates Albumin is used for treatment of shock caused by blood loss trauma or burn, raised intracranial pressure caused by hydrocephalus or trauma, edema or ascites caused by hepatocirrhosis and nephropathy, prevention and treatment of low-density-lipoproteinemia and neonatal hyperbilirubinemia. It is included in provincial essential drug lists of certain provinces and categorized as Class B in China s National Drug Reimbursement List

11 IVIG: Early-stage Market with Strong Growth Drivers 10 Largest product category globally yet still at an early-stage in China Growth of IVIG market will be driven by expanded indications and physician education Per Capita usage in China is less than 10% of that in U.S. IVIG s pricing in China is currently less than half of that of the US, providing strong upside potential ($ MM) 1, IVIG Sales in China IVIG Per Capita Usage in 2015 (Kg per MM Inhabitants) x China United States Source: The Marketing Research Bureau, Inc. and Company estimates IVIG is used for treatment of hereditary immunoglobulin deficiency, such as X chain low immunoglobulin, familial variable immune deficiency, immunoglobulin G secondary deficiency; secondary immunoglobulin deficiency, such as severe infection, newborn sepsis; and auto-immune deficiency diseases, such as original thrombocytopenia purpura or Kawasaki disease. It is included in provincial essential drug lists and categorized as Class B in China s National Drug Reimbursement List

12 Factor VIII: Nascent Market, Strong Growth Potential and Highly Profitable 11 Factor VIII is a life saving and a lifelong treatment Room for significant growth for Factor VIII products in China Only 8 domestic manufacturers in the plasma-derived Factor VIII segment Over 15,000 (1) registered hemophilia patients in China, many more unregistered Primarily acute usage vs. little preventive usage, providing huge room for growth Recombinant Factor VIII is not competitive due to higher cost and lack of insurance coverage ($ MM) 40 Factor VIII (2) Sales in China Factor VIII (2) Per Capita (International Usage in Units 2015 per Inhabitant) x China United States Source: The Marketing Research Bureau, Inc. and Company estimates 1. As of December 31, 2016, according to China Hemophilia Association 2. Excluding recombinant products Factor VIII is used for treatment of coagulopathie such as hemophilia A and increase concentration of coagulation factor VIII. It is included in national essential drug lists and categorized as Class A in China s National Drug Reimbursement List

13 Company Overview China Biologic Products Holdings, Inc.

14 The Only Offshore Investment Opportunity in the Attractive Chinese Plasma Industry 13 1 Leading Plasma Player in China 2 Stable and Growing Plasma Supply 3 Leader in China s Fast Growing IVIG Market 4 Strong Product Pipeline Enhancing Margins and Leadership 5 Robust Cash Flow and Sustainable Profitability 6 Professional and Experienced Management Team

15 1 Leading Plasma Company in China - Solid Track Record of Delivering Sustainable Profitability 14 The largest domestic plasma player in China in terms of 2015 total sales * * source: MRB report ($ MM) Total Sales ($ MM) Unique distribution model, products sold directly to ~600 hospitals and clinics Operating Cash flow and Recurring Operating Income M'16 9M' ($ MM) Non-GAAP Net Income Attributable to Equity Holders (1) E 9M'16 9M' Operating Cash Flow Operating income E 9M'16 9M'17 1. Non-GAAP net income attributable to equity holders excludes non-cash employee stock compensation and some non-recurring items. Refer to Appendix I for reconciliations. * Subject to foreign exchange translation impact

16 1 Leading Plasma Player in China 15 Advantages from Leading Market Position Product portfolio consisting of eight plasma products with strong economics High product quality and safety record Large scale and reliable product supply to hospitals Government support for leading players

17 2 Growing and Sustainable Plasma Supply 16 Strong plasma supply growth: annual plasma collection 2012 to 2016 CAGR CBPO: 16% V.S. China Average: 14%* * Source: data published by National Health and Family Planning Commission of the PRC and company estimates. Cao County Plasma Collection Center, Shandong Province Xinglong Plasma Collection Center, Hebei Province Full year plasma collection volume surpassed one thousand metric tons for the first time combining internal plasma collection and outsourced plasma through strategic collaboration with a third party fractionator Extensive plasma collection network of 14 captive plasma stations (including 1 branch station) With Xinglong plasma station opened in June 2016, plasma collection network now covers 33 cities and counties within four provinces with an aggregate population of approximately 42.6 million Obtained approvals to build a new plasma collection station and a branch collection facility in Shandong province in December 2016 Daming collection station in Hebei Province is expected to commence operation in 2017 Continue to explore new regions to expand plasma donor coverage Drive plasma collection growth volume at our existing stations

18 3 Leader in China s Fast Growing IVIG Market 17 China s IVIG Market Has Substantial Growth Potential Low per capita Consumption of IVIG in China Sustainable Growth Drivers 2015 (Kg per MM Inhabitants) x 210 Enhancing Physician Education China United States Expanding Therapeutic Indication Improving Insurance Reimbursement CBPO s Increasing Sales in IVIG One of Leading Players in China s IVIG Market ($ MM) % 32.3% IVIG Sales % of Total Sales 2016 (based on 2016 Production volume) Others CBPO 14.9% Domestic player 1 Domestic player 2 Source: The Marketing Research Bureau, Inc., and Company estimates 1. Excludes sales attributable to Xi an Huitian, in which we hold a 35% non-controlling stake

19 4 Robust and Low Risk Product Pipeline Enhancing Margins and Leadership 18 Products Preclinical Research Clinical Trial Application Clinical Trial Commercial Launch Development Status Human Fibrinogen Received approval of Fibrinogen by the CFDA in October and aim to commercially launch this product in early Immune Globulin Intravenous (Human), Caprylate/Chromatography Purified and 20 nm virus filtration Obtained the approval for clinical trial by CFDA Human Antithrombin III Obtained the approval for clinical trial by CFDA Human Cytomegalovirus Immunoglobulin Obtained the approval for clinical trial by CFDA Human coagulation factor IX Obtained the approval for clinical trial by CFDA Human Fibrin Sealant Completed the official virus inactivation by the PRC National Institutes for Food and Drug Control. Completed the animal experiments for safety and effectiveness.

20 4 Robust and Low Risk Product Pipeline Enhancing Margins and Leadership (continued) 19 Each new product will incrementally improve profit Indicative Revenue and Profit Breakdown per Liter of Plasma Total Fractionation Revenue Hyper-Immune Products Profit IVIG Cost Albumin ImmunoglobulinFactor VIII PCC Other Products

21 5 Robust Cash Flow Generation 20 Operating Cash Flow Capital Expenditures ($ MM) ($ MM) M'16 9M' M'17 mainly for Shandong Taibang s new fractionation facility

22 Planned New Facility in Shandong 21 Shandong Taibang New Fractionation Facility Scheduled open time: end of 2017 Estimated Investment: RMB 800-1,000 million Fractionation capacity: expanding to a minimum of 1,200 metric tons from 700 metric tons

23 6 Professional and Experienced Management Team 22 Mr. David (Xiaoying) Gao, Chairman & Chief Executive Officer Mr. Ming Yang, Chief Financial Officer Mr. Ming Yin, Senior Vice President CEO since May 2012, Chairman of the Board since March 2012 and Director since 2011 Over 20 years of experience in corporate governance and management, especially in healthcare and technology sectors Previously served as CEO & Director of BMP Sunstone Corporation and integration advisor post acquisition by Sanofi in 2011 Former member of board of Asia-Pacific operations, Motorola M.B.A. from Massachusetts Institute of Technology, M.S. in Mechanical Engineering from Hanover University, Germany, and B.S. in Mechanical Engineering from Beijing Institute of Technology CFO since August 2012 and VP- Finance & Compliance and Treasurer between March 2012 and August years in financial management and 11 years of audit experience in accounting firms including audit senior manager at KPMG C.P.A. in China Senior Corporate Vice President since August 2012, joined in years of financial management experience and 7 years of investor relations experience C.F.A.

24 Future Growth Drivers 23 Organic Growth is Our Strategic Focus and Priority Improve collection volume at existing centers Establish more collection centers and enlarge collection territories Source raw material through strategic collaboration Increased Plasma Collection Ongoing Innovation Explore new products by internal R&D and external cooperation Improve yield of existing products Increase our stake in existing subsidiaries Further consolidate subscale players in the industry Expand into complementary business through possible acquisition or partnership Potential M&A Expand Sales Model Further develop direct sales model Partner with major distributors in tier-one cities to dominate high end market Timely adjust sales model for regulatory change Develop marketing initiatives and execution

25 Why Invest in CBPO and the Highly Attractive Plasma Sector? 24 1 China Plasma Market in Early-Stage of Development with Significant Growth Potential 2 High Entry Barrier Creating A Seller s Market 3 A Leading Player with Substantial Competitive Advantages 4 Superior Capability of Generating High Growth with Sustainable Profitability and Robust Cash Flow

26 Income Statement and Balance Sheet Highlights 25 $ MM M 16 9M 17 Total sales Cost of sales Gross profit M 17 Total Cash (1) ($ MM) Cash & Cash Equivalents ($ MM) Operating expenses Selling expenses Restricted Cash and Deposit ($ MM) G&A expenses R&D expenses Income from operations Income before income taxes Net income Time Deposits ($ MM) Short-term and Long-term Bank Loans ($ MM) Accounts Receivable Days Inventory Days Net income attributable to CBPO Calculated as the sum of cash & cash equivalents, restricted cash and deposits, and time deposits.

27 Appendix China Biologic Products Holdings, Inc.

28 Appendix I 27 Reconciliation of Non-GAAP Net income Attributable to Equity Holders $ MM, except EPS in $ and number of shares in MM Net Income Attributable to Equity holders Non-cash employee stock compensation Gain (loss) from change in fair value of warrants Adjusted Net Income Attributable to Equity holders - Non GAAP M 16 9M Diluted EPS - Non GAAP Weighted average number of shares used in computation of Non GAAP diluted EPS

29 Appendix II - Plasma Donor Management 28 Five steps to assure safe plasma from healthy donors I. Facial identification II. Five times fingerprint identification III. ID card identification system IV. Physical examination before donating plasma to assure up to standards for HBsAg, HCV, HIV, ALT, and syphilis V. Fully-automatic plasma collection machine; fully enclosed and disposable medical instruments China Biologic Products Holdings Fuping Plasma Collection Center in Shaanxi

30 Appendix II - Plasma Donor Management 29 Safety measures in every production phase Reducing safety risks of plasma collection with a TRIPLE virus detection defense system First day of plasma donation Plasma checking by collection station 1 Disqualification Qualification Plasma rechecking by fractionator Qualification 2 Disqualification Destruction plasma waiting period for 110 days at least Another plasma donation by the same donor after 90 days Checking of re-donated plasma by fractionator 3 Disqualification Qualification Plasma collected on first day goes to production

31 Contacts 30 China Biologic Products Holdings, Inc. Ming Yin, Senior Vice President 18th Floor, 19 Chaoyang Park Road Chaoyang District, Beijing , PRC. China: KPMG Davis Polk & Wardwell LLP Independent auditor Legal counsel IR Agent ICR LLC Bill Zima, Partner China: U.S.: For more information please visit us at:

32 THANK YOU